Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2025-12-24 @ 9:13 PM
NCT ID:
NCT06384404
Eligibility Criteria:
Inclusion Criteria:
* Patients must have newly diagnosed, previously untreated, localized, high-grade osteosarcoma of an extremity (verified by histopathology) with plans to undergo upfront surgical resection of the tumor followed by systemic chemotherapy.
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2 (Karnofsky will be used for patients \>16 years of age and Lansky score for patients \<= 16 years of age)
Exclusion Criteria:
* Patients with metastatic disease at diagnosis
* Initiation of systemic therapy prior to enrollment
* Prior history of cancer
* Prior radiation therapy
* Active life-threatening infection
* Pregnancy (negative pregnancy test result must be obtained for female patients of childbearing potential)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
40 Years
Study:
NCT06384404
Study Brief:
Protocol Section:
NCT06384404